Z-1254-2010

Qwix 4.3mm Stabilization Screws - 34mm

Name: Z-1254-2010 Qwix 4.3mm Stabilization Screws - 34mm
Creator: Integra LifeSciences Corporation
Published: 2010-02-08
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-02-08 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corporation began a recall of Qwix 4.3mm Stabilization Screws - 34mm on 2010-02-08. The reason FDA records is "The screws were etched incorrectly as 32mm instead of the correct 34mm length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1254-2010
Status: Terminated
Initiated: 2010-02-08
Posted: 2010-04-07
Terminated: 2011-10-27
Recalling firm: Integra LifeSciences Corporation
Product: Qwix 4.3mm Stabilization Screws - 34mm
Product code: HWC Screw, Fixation, Bone
Reason for recall: The screws were etched incorrectly as 32mm instead of the correct 34mm length.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified via conference calls and/or FedEx mailing. Recall aknowledgement forms were provided with written notification. This requires consignees to review their inventory and to indicate any affected lots . This form requires a signature and must be returned.
Distribution: Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah.
Product codes and lots: Part Number: 111434SND Lot Number: E6DO

Product code HWC

K050346Class IIStabilization ScrewNew Deal, S.A. / cleared 2005-03-17

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)